1550nm Non-ablative Fractional Vs 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss

Официальное название

A Prospective, Randomized, Evaluator-blind, Clinical Trial Evaluating the 1550nm Non-ablative Fractional or 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss

Обзор

To evaluate the efficacy of either a 1550nm non-ablative fractional laser or a 1927nm thulium fractional laser in the treatment of female pattern hair loss (FPHL).

Подробное описание

The study will have a total of eight visits, from baseline (Day 0) to the final follow-up at 3 months following the last treatment. The first visit (Visit 1, Day 0) will be for screening. During this visit, informed consent, HIPAA authorization, and a photo release will be obtained from all participants. Investigators will review the inclusion and exclusion criteria, medical history, and any concurrent medications. A urine pregnancy test will be administered for all eligible subjects. Baseline hair loss will be evaluated and standardized 2D photographs will be taken for future comparison. Hair count, hair density, and terminal hair average diameter will be evaluated as a pre-defined scalp location.. Patients will be randomized to groups (Group A or B).Visits 2 through 5 (Day 30, 60, 90, and 120, ± 5 days) will consist of the treatment phase. Participants will be treated based on which treatment group they were randomized too as below

Вмешательства

• Устройство 1550nm non-ablative fractional laser
  Treatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp.
• Устройство 1927 thulium fractional laser
  Treatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp.

Первичные конечные точки

• Change in hair count at a predefined 1cm x 1cm scalp location [Срок оценки: Baseline and Day 180]
• Change in hair density (hairs/cm) at the same predefined scalp area [Срок оценки: Baseline and Day 180]
• Change in terminal hair average diameter (in mm) at the predefined location [Срок оценки: Baseline and Day 180]

Вторичные конечные точки (5)

• Change in Sinclair Scale score [Срок оценки: Baseline and Day 180]
• Change in perceived age based on blinded evaluator assessment of global scalp photographs [Срок оценки: Baseline and Day 180]
• Subjective Assessment on Hair outcomes [Срок оценки: Day 180]
• Physician Global Aesthetic Improvement Scale (PGAIS) via photos by blinded evaluator [Срок оценки: Day 180]
• Comfort Level Visual Analog Scale [Срок оценки: Baseline, Day 30, Day 60, Day 90]

Критерии участия

Критерии включения

• Adult women aged 35-65 years
• Fitzpatrick skin types I-IV
• Presence of female pattern hair loss of the frontal or vertex of scalp (Sinclair (II-IV)
• Must be willing and can comply with all study protocols, including all treatment schedules, follow up visit, assessments, sign a photography release and ICF, and complete the entire course of the study
• Patients with gray hair roots must be willing to dye their gray hair within two weeks of the first appointment and the last 3-month follow-up visit to ensure consistency in evaluator assessments.
• No use of hair growth treatments or procedures within 6 months prior to enrollment (including hair supplements such as Nutrafol)
• Subjects in good general health based on investigator's judgment and medical history
• Negative urine pregnancy test result at the time of study entry
• Subjects will be of non-childbearing potential defined as:
• Having no uterus
• No menses for at least 12 months.
• Or;
• Subjects of childbearing potential must agree to use an effective method of birth control during the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation. Acceptable forms of birth control below:
• Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
• Intrauterine coil
• Bilateral tubal ligation
• Hysterectomy
• Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
• Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
• Vasectomized (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized partner).

Критерии исключения

• No surgery, pregnancy, breast feeding, change in or addition of hormonal contraception in the last 6 months
• No history of iron deficiency anemia, vitamin D deficiency, or thyroid disease (hypothyroidism or hyperthyroidism or currently on thyroid supplementation)
• Use of scalp light or with laser treatment within the last 6 months.
• Use of topical or systemic drugs affecting hair growth within 6 months prior to enrollment (such as oral spironolactone, finasteride, oral or topical minoxidil, and supplements marketed for hair growth such as Nutrafol)
• Supplementation of oral tumeric/curcumin
• History of hair transplant
• Systemic or scalp disease that may affect hair growth (Lupus, alopecia areata, folliculitis decalvans, psoriasis, scalp infection, seborrheic dermatitis, CCCA, telogen effluvium)
• Pregnancy or planned pregnancy during the study or currently breastfeeding.
• Any uncontrolled systemic disease
• History of autoimmune connective tissue disease or thyroid disease.
• Current use of immunosuppressive medication.
• Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• Active dermatitis, metal or other active implants, active infection in the proposed treatment area.
• Subjects with scarring in the treatment areas (scalp) Subjects with a history of keloids will be excluded.
• History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease, history of Bell's Palsy, epilepsy, smoking, pregnancy, and lactation.
• Inability to following the comply with study protocols and regulations
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• West Dermatology Research Center/Cosmetic Laser Dermatology — San Diego

Идентификаторы

NCT: NCT06926023 · Hair-1550-vs-1927

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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